Optical cup

ABSTRACT

The present invention relates to a system for conducting the identification and quantification of micro-organisms, e.g., bacteria in biological samples. More particularly, the invention relates to a system comprising a disposable cartridge and an optical cup or cuvette having a tapered surface; wherein the walls are angled to allow for better coating and better striations of the light, an optics system including an optical reader and a thermal controller; an optical analyzer; a cooling system; and an improved spectrometer. The system may utilize the disposable cartridge in the sample processor and the optical cup or cuvette in the optical analyzer.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/409,675 filed Nov. 3, 2010, which is hereby incorporated byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a system for conducting theidentification and quantification of micro-organisms, e.g., bacteria inbiological samples such as urine. More particularly, the inventionrelates to a system comprising a disposable cartridge and an optical cupor cuvette having a tapered surface; an optics system including anoptical reader and a thermal controller; an optical analyzer and animproved spectrometer. The system may utilize the disposable cartridgein the sample processor and the optical cup or cuvette in the opticalanalyzer.

2. Description of Related Art

In general, current-day practice for identifying micro-organisms, e.g.,bacteria in urine samples, involves a complex, lengthy, and expensiveprocess for identifying and specifying micro-organisms in microbiologylabs. In the current process, the samples are accepted into the lab.These specimens are then sorted, labeled, and then they are inoculatedonto blood agar medium using a sterilized loop. The specimens are theninserted into a dedicated incubator for a 24-hour period. A day later,the lab technicians screen the specimens for positive and negativecultures. In general, most of the cultures are negative and they aremanually reported. The organisms for the positive cultures are isolatedand suspended in a biochemical fluid. This involves suspension,dilution, vortexing, and turbidity measurements resulting in biochemicalwaste products. The cultures are then subjected to a speciesidentification and antibiotics susceptibility testing exposing thesuspensions to multiple reagents. After another 6 to 24-hour incubationperiod, the findings are interpreted and reported by lab technicians.This entire process generally takes 11 steps and 50 hours to obtainspecimen results and the process is labor intensive.

Commonly owned U.S. Patent Application Publication No. US 2007/0037135A1, the contents of which are herein incorporated by reference,discloses a system for identification and quantification of a biologicalsample suspended in a liquid. As disclosed in the reference samplecuvettes are used for holding the biological sample. The referencestates that these cuvettes are said to be well known in the art, aretypically square or rectangular in shape (having a well area to containthe sample), and are made of a transparent material such as glass or apolymeric material. However, the reference fails to disclose anyspecific description/design of the cuvettes.

There is a need, therefore, particularly for species identification ofthe above lab procedure to provide a more efficient and less timeconsuming process which requires less labor. There is also a need for animproved design for an optics cup or cuvette and a method formanufacturing the optics cup cuvette or for holding samples, whichoptics cup or cuvette may be used in a system for an optical analysis ofthe sample.

SUMMARY OF THE INVENTION

The system of the invention streamlines the current system for obtainingspecimen results. The system is environmentally friendly, enables arapid diagnosis, results are consistent, no reagents are needed, andthere is a multifunctional diagnosis. According to one embodimentdisclosed in commonly owned PCT Patent Application Publication No. US2008/079533, biological samples are contained within disposablecartridges which hold four disposable components, i.e., a centrifuge,two pipette tips with a different volume, and an optical cuvette. Thecartridges are bar coded and tied in with the patient's ID. Thecartridges are inserted in a magazine which is then inserted into asample processor which processes the specimens. The prepared specimensare transferred into the optical cuvettes and then the magazine isinserted into an optical analyzer which analyses the specimens. Theoptical analyzer analyses and generates the complete results enablingultimate treatment of the bacteria. The system does not require asophisticated operator and gives rapid results.

According to an alternative embodiment, the system includes a pluralityof disposable cartridges for holding a plurality of disposablecomponents including a centrifuge tube, a pipette tip having a 1 mlvolume, and an optics cup or cuvette containing a biological specimen,such as urine, wherein the optics cup or cuvette is specifically shapedto optimize analysis of the contents. Each cartridge is bar coded andtied to a urine specimen of a patient. The centrifuge tube and thepipette tip may generally be used for processing or preparing the urinespecimen for analysis and the final processed urine sample is thentransferred into the optics cup or cuvette for optical analysis in anoptical analyzer. The optics cup or cuvette includes a container thathas a lower tapered area in order to assist with the optical analysis.That is, the ultraviolet (UV) light source used in the optical analysiscan be directed into the optics cup or cuvette. The optics cup orcuvette may be made of a transparent material, for example ABS plasticor glass, or it may be made of a metallic material, e.g., aluminum. Ifthe optics cup or cuvette is made of a transparent material, then,preferably, it is coated or layered with a reflective material. Inparticular, an inner surface of the optics cup or cuvette is coated witha reflective material or contains a layer of reflective material. One ormore disposable cartridges may be inserted into a magazine, which canthen be inserted into a sample processor and/or into an opticalanalyzer. As many as 42 urine samples may be processed and thenoptically analyzed while being supported in an optics cup or cuvettewhich, in turn, is supported in a disposable cartridge of the invention.The samples or specimens may be biological samples, chemical samples, ortoxicant samples, including, for example, urine samples for the opticalanalysis of contaminants, e.g., bacteria.

In an additional embodiment, the present invention relates to an opticscup or cuvette referred to above for holding a sample, e.g., biologicalsample, chemical sample, or toxicant sample, e.g. urine for opticalanalysis. If the sample is a urine sample, then the optical analysiswould be for micro-organism or organisms, e.g. bacteria in the urine.The optics cup or cuvette may be a rectangular-shaped container, andpreferably an injection molded plastic having an upper rectangularopening and a tapered area extending inwardly and downwardly relative tothe rectangular opening.

In an additional embodiment, the optical cup or cuvette includes arectangular-shaped container having a lower tapered area, arectangular-shaped top opening for receiving the biological fluidspecimen, and an inner reflective surface. The container also includestwo spaced-apart sidewalls, a first and second end wall and a horizontalfloor. The first end wall has a lower tapered area which is contiguousto the horizontal floor. The lower tapered area is angled about 44.0°relative to a vertical plane or axis extending through the optics cup or46.0° relative to a bottom portion of the second wall. The spaced apartside walls are angled with respect to each other at an approximately 3°angle with respect to the vertical axis or plane extending between asample fill-line location on the walls of the optical cup and the topopening forming a total angle offset of 6°. The second end wall isangled at approximately 1°-3° with respect to a vertical axis. The topportion of the second end wall is angled an additional 0°-2° withrespect to the vertical plane or axis extending from the samplefill-line extending from the floor of the cup location forming a totalangle of 3° for the second end wall with respect to the vertical planeor axis extending through the optics cup.

In another aspect, the disposable optical cup or cuvette also has aflange along the perimeter of the rectangular-shaped opening at the topof the container for supporting the optical cup or cuvette, preferably,in a disposable cartridge during optical analysis of the biologicalfluid specimen and which optical analysis generally involves an opticalreader.

According to another aspect of the invention, the optical reader foranalyzing bacteria in the biological specimen includes the optics cupcontaining the biological specimen and an illumination arrangementincluding a xenon light source and a system of turning minors, filtersand a filter wheel supported in a plurality of carriages for producingan illumination beam. The plurality of carriages are arranged at anangle so as to decrease the distance between the light source and theoptics cup and to increase the signal-to-noise ratio of the illuminationbeam. The optical reader also includes an anchor shoe for supporting theoptics cup and having a slit for producing a collimated beam from theillumination beam and directing the collimated beam into the optics cupand an optical collection device for receiving the fluorescent emissionsof the collimated beam from the urine specimen and the optics cup anddirecting the fluorescent emissions to a detection device for theanalysis of bacteria in the urine specimen.

According to another aspect of the invention, there is provided a methodfor increasing the signal-to-noise ratio of a collimated beam generatedin an optical reader for the optical analysis of a biological specimencontained in an optics cup. The method comprises providing a lightsource for producing an illumination beam; directing the illuminationbeam into a first optical system including a filter and a turning mirrorso as to bend the path of travel of the illumination beam of the lightsource; directing the illumination beam produced in step b) into asecond optical system including a filter and a turning mirror so as tobend the path of travel of the illumination beam produced in step b) ata 45° angle; and directing the illumination beam as a result of step c)into a slit to produce a collimated beam which is directed into theurine specimen in the optics cup to produce fluorescent emissions whichare directed to an optical collection device and then to a detectiondevice for the analysis of bacteria in the urine specimen.

In an embodiment of the invention, the optical cup or cuvette includes aribbon liner for light collection and reflection through the sample forthe optical analysis of the sample. The ribbon liner may be made of areflective material, for example, a piece of stamped aluminum, which maybe shaped and formed to partially or totally clad the inner surface ofthe container including the tapered area. The ribbon liner may besecured to the container via a crimping process wherein the ends of theribbon liner are fastened to the flanges of the rectangular opening ofthe container, or via a one-way retention tab, or via one or two heatstaked pins, or via a snap mechanism which may be tooled out of the sideof the container. These means for securing the wet ribbon liner to theinner surface of the container are well-known to those skilled in theart. For example, the one-way retention tab includes the containerhaving a post which has small “teeth” and the liner having a hole oropening and once the liner is positioned over the post, the “teeth” ofthe post prevent the liner from being moved. A heat stake pin isgenerally smooth and once the liner is positioned on the pin, heat isused to deform the end so that the liner cannot slip out of thecontainer.

In a further embodiment of the invention, the inner surface of thecontainer is partially or totally coated with a layer of aluminumthrough a process selected from the group consisting of a vacuummetallization process and an electroplating process. In a furtherembodiment of the invention, the container may be a two-piececonstruction having an upper piece with a rectangular opening forreceiving the urine sample and a lower piece having a tapered area forre-directing light. The upper and lower pieces are bonded together andthe lower piece can contain a ribbon layer of a reflective material or acoating of reflective material, for example, aluminum. The bondingprocess may be selected from the group consisting of an ultrasonic buttwelding process, an ultrasonic shear welding process, a press fitprocess, a snap fit process and a solvent weld process using a press fitprocess or a snap fit process.

The disposable cartridge of the invention for containing the disposablecomponents, including the optics cup or cuvette discussed above can beformed by an injection molding process from a well-known plasticmaterial, such as an ABS plastic. The disposable cartridge containsseveral compartments for positioning and supporting the severaldisposable components such as the centrifuge tube, pipette and opticscup or cuvette discussed hereinabove. The compartments for positioningand supporting the centrifuge tube and pipette generally are cylindricalin shape so as to receive the cylindrical shapes of the centrifuge tubeand pipette and better support these components within the disposablecartridge. However, the compartment for positioning and supporting theoptics cup or cuvette, particularly if the optics cup or cuvette isrectangular-shaped, need not be molded in the same configuration as theoptics cup or cuvette. In this instance, the compartment for the opticscup or cuvette in the disposable cartridge may, in general, include arectangular-shaped opening located in the top surface of the disposablecartridge wherein a top flange of the optics cup or cuvette engages andis supported by the top surface of the disposable cartridge and theoptics cup or cuvette is suspended within the disposable cartridge.

In one embodiment, the system includes a plurality of disposablecartridges for holding a plurality of disposable components including: acentrifuge tube; a pipette tip; and an optical urine sample cuvette; asample processor for receiving the plurality of disposable cartridgesand configured to process and prepare the urine sample of eachdisposable cartridge and to transfer the urine samples into therespective optical cuvette of each of the disposable cartridges; and anoptical analyzer for receiving the cartridge with the optical cuvettescontaining the processed urine samples and analyzing and generating thespecimen results. The entire process of processing the urine specimensin the sample processor and analyzing them in the optical analyzer takesabout 30 minutes for a single specimen and up to 2 hours for 42specimens.

The disposable cartridge and the disposable components of the presentinvention provide advantages over the currently used cartridges andcomponents as they increase efficiency, improve workload and save timeand money since the components necessary for the preparation orprocessing of the urine samples are conveniently located in one place,i.e., in a cartridge. Additionally, less manpower or manual handling ofthe components is required for the processing/analyzing of the urinesamples. There is also the added convenience in that the cartridge andits components are disposable. That is, these items do not need to besterilized for the next urine specimen identification process andcontamination of the work area and/or surrounding environment isminimized.

According to another aspect of the invention, there is provided a systemfor cooling and controlling the temperature of a sample, e.g. urinesample in an optics cup or cuvette for optical analysis and the systemmay be located in an optical analyzer which performs analysis of one ormore samples.

In an additional embodiment, the system of the present inventionincludes: a carousel for supporting a plurality of disposablecartridges, each supporting a disposable optics cup or cuvettecontaining a sample or specimen to be optically analyzed by an opticalanalyzer and having a plurality of openings, each associated with one ofthe disposable cartridges; a turntable having a plurality of openingseach associated with one of the openings in the carousel; a tubingsystem surrounding the turntable for carrying chilled air from a thermalelectrical (TE) cooler to the turntable and cool air from the turntableto the TE cooler; and a fan associated with the tubing system forcirculating chilled air through the plurality of openings in theturntable to cool and to control the temperature of the specimens. Theturntable, preferably, is made of aluminum, and the optics cups orcuvettes and disposable cartridges are preferably made of plasticthereby enabling convective cooling to occur through the aluminummaterial and the plastic material for rapidly cooling the specimens andthen maintaining the specimens at a desired temperature during theoptical analysis of the specimens or samples.

In one embodiment, the system of the invention may be located in anoptical analyzer and may be adapted to cool the specimens from ambienttemperature down to a desired temperature, for example, about 18° C.within about 5 minutes after start up of the optical analyzer and thencontrolling the temperature of the samples to within ±0.5° C. of thedesired temperature until the optical processing of the samples in theoptical analyzer is completed. The openings in the turntable are about0.156-inch holes and deliver an air flow rate ranging from about 15 toabout 10 cubic feet per minute. The temperature of the chilled watertraveling from the TE cooler to the turntable is maintained at ±0.1° C.of the cool down temperature, and the rate of flow of the cooling watertraveling from the turntable to the TE cooler is about 0.5 to about 1.0gallons per minute.

A further embodiment of the present invention provides a system forcooling and then controlling the temperature of a specimen in an opticscup or cuvette during optical analysis, including: a carousel forsupporting a plurality of disposable cartridges which support aplurality of disposable optics cups or cuvettes, each containing aspecimen to be optically analyzed by an optical analyzer, and having aplurality of openings, each associated with one of the disposablecartridges; a turntable having a plurality of openings, each associatedwith one of the openings in the carousel; and an aluminum block locatedbelow the turntable and having a plurality of passageways in associationwith the turntable for carrying chilled air from a TE cooler to theturntable and cool air from the turntable to the TE cooler for coolingthe samples and then controlling the temperature of the specimens.

In one embodiment the present invention provides a system for coolingand controlling the temperature of the samples being subjected to anoptical analysis so that the signal of the specimens may be maintainedfor an adequate analysis of the organisms in the specimens.

In yet another embodiment, the present invention provides an improvedarrangement for a spectrometer for use in an optical reader foroptically analyzing a specimen. The spectrometer includes a collectionlens system for receiving an illumination beam from the optics cup orcuvette containing the specimen; a spectrometer slit arranged adjacentthe collection lens system through which the illumination beam travelsin a first optical path after exiting the optics cup or cuvette; a firstcylindrical lens located adjacent the spectrometer slit for receivingthe illumination beam in its first optical path; a first mirror forcollimating the illumination beam traveling through the firstcylindrical lens and for reflecting the illumination beam into a secondoptical path; a plane diffraction grating located in the second opticalpath of the illumination beam for receiving the illumination beamreflected from the first mirror, for dispersing the illumination beaminto its spectral components to form a plurality of dispersed beams andfor reflecting the dispersed beams along a third optical path; a secondmirror in the third optical path; a second cylindrical lens positionedrelative to the second mirror for receiving and focusing the pluralityof dispersed beams toward the second cylindrical lens in a fourthoptical path; and a CCD device allocated adjacent the second cylindricallens for receiving the plurality of dispersed beams traveling throughthe second cylindrical lens for the analysis of the presence ofcontaminants, e.g. bacteria in the specimen, e.g. biological fluid,e.g., urine.

In one embodiment, the first and second cylindrical lenses arepreferably 3-inch spherical mirrors having ultraviolet (UV) lenses madeof fused silica material. The first cylindrical lens is preferablylocated about 10.7 mm from the spectrometer slit. The first mirror islocated closer to the slit than the second mirror and the first mirrorand the second mirror have a radius of about 360 m. The grating ispreferably a 3-inch grating, preferably having 1200 lines per millimeter(lpm) and blazed 10.4° for a 300 nm wavelength region. The CCD includesa 25 mm length detector.

In one embodiment the present invention provides an improvedspectrometer for the optical reading of bacteria in a urine specimenwhich increases the throughput in a spectrometer.

In a further embodiment, the present invention provides an improvedarrangement for a spectrometer useful in a system which has lowresolution and high sensitivity conditions.

In one aspect of the invention, the optical analyzer contains an opticssystem, a thermal control, and a drawer which has a rotatable table forreceiving, supporting, and rotating a magazine containing a plurality ofdisposable cartridges with optical cups or cuvettes which contain theurine samples to be analyzed. The optical analyzer also contains a barcode reader for inventorying the urine samples. When the drawer with themagazine is inserted into the optical analyzer, the drive mechanism forthe rotatable table supporting the magazine rotates and registers themagazine relative to the bar code reader and then rotates and registersthe magazine relative to the optics system. The optics system includesan excitation module unit, an optical collection unit, and aspectrometer. The temperature of each cup or cuvette is decreased to atemperature which will slow the metabolism of the bacteria in the urinesamples while increasing the fluorescence signal. A thermal controlcools a large thermal mass, which is located on the rotatable tableunderneath the magazine containing the disposable cartridges, with urinesample cups or cuvettes.

In one embodiment, a related method for identifying the type ofmicro-organism and quantifying it in a urine sample includes the stepsof obtaining a urine sample; passing the urine sample through a 10micron filter; obtaining a 2 ml sample of the filtered urine and placingit into a centrifuge tube; obtaining a 1,000,000:1 dilution of thedissolved materials in the urine retaining bacteria in the urine sampleby centrifuging the 2 ml sample at about a 12,000 g-force, decantingabout 95% of the fluid in the centrifuge tube, replacing the decantedsolution with a saline solution, and repeating these steps about fivetimes; transferring the final solution into an optical cup or cuvette;and subjecting the optical cup or cuvette to an optical analysis havingoptics, which include exciting the urine sample with at least fivedifferent wavelengths, collecting and detecting the fluorescentemissions; and directing the fluorescent emissions into a spectrometer.The fluid sample may be for example a biological, chemical or toxicantsample, e.g., urine sample which is optically analyzed, for example, forthe type and amount of organism or micro-organism, e.g., bacteria in thesample.

In an additional embodiment, the fluid sample may be for example abiological, chemical or toxicant sample, e.g., urine sample which isoptically analyzed, for example, for the type and amount of organism ormicro-organism, e.g., bacteria in the sample.

These and other objects and advantages of the invention will be madeapparent from the following description taken together with thedrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a top perspective view of a magazine having a plurality ofdisposable cartridges;

FIG. 1B is a top perspective view of a disposable cartridge used in themagazine shown in FIG. 1A;

FIG. 2 is a front sectional view illustrating the components of thedisposable cartridge of FIG. 1B in phantom;

FIG. 3A is a perspective view of a sample processor illustrating inphantom the several components of the sample processor of the system ofthe invention;

FIG. 3B is an additional perspective view of a sample processorillustrating in phantom the several components of the sample processorof the system of the invention;

FIG. 4A is a perspective view of an optical analyzer illustrating inphantom the several components of the optical analyzer of the system ofthe invention;

FIG. 4B is a perspective view of an optics system illustrating inphantom the several components of the optics of the system of theinvention;

FIG. 4C is an additional perspective view of an optical analyzerillustrating in phantom the several components of the optical analyzerof the system of the invention;

FIG. 5 is a schematic illustrating mirrored convex “horn” that may beprovided at the entrance of a slit of a spectrometer;

FIG. 6 is a perspective view of a centrifuge illustrating in phantom theseveral components of the centrifuge of the system of the invention;

FIG. 7 is an additional perspective view of a sample processorillustrating in phantom the several components of the sample processorof the system of the invention;

FIG. 8A is a perspective view of a disposable cartridge according to analternative embodiment of the invention for supporting the disposablecomponents including an optics cup;

FIG. 8B is a cross sectional view taken along line IX A-IX A,illustrating the disposable cartridge of FIG. 8A and the disposablecomponents including an optics cup which is shown in phantom;

FIG. 8C is a top perspective view of a magazine having a plurality ofthe disposable cartridges of FIGS. 8A and 8B;

FIG. 8D is a perspective view of the disposable cartridge withoutdisposable components of FIG. 8A showing attachment clips for securingthe cartridge within the magazine;

FIG. 8E is a side elevation view of the cartridge of FIG. 8D;

FIG. 8F is an opposite side elevation view of the cartridge of FIG. 8D;

FIG. 9A is a perspective view illustrating an optics cup according toone embodiment of the present invention with an aluminum ribbon linerpartially covering the inner surface of the container of the optics cup;

FIG. 9B is a perspective view illustrating an optics cup according toone embodiment of the present invention with an aluminum liner totallycovering the inner surface of the container;

FIG. 9C is a partially enlarged perspective view illustrating a portionof the ribbon liner of FIG. 9A attached via a crimping process to aflange of the optics cup of the present invention;

FIG. 9D is a front perspective view illustrating an optics cup accordingto another embodiment of the present invention;

FIG. 9E is a side view of the optics cup of FIG. 9D;

FIG. 9F1 is a front view of the optics cup of FIG. 9D;

FIG. 9F2 is a cross-sectional view taken along lines “A-A” in FIG. 9E.

FIG. 9G is a cross-sectional view of the optics cup taken along line“B-B” of FIG. 9F1;

FIG. 9H is a top view of the optics cup of FIG. 9D;

FIG. 9I is a detailed view of the snap portion on the flange denoted byI in FIG. 9G;

FIG. 10 is a top plan view illustrating the inner surface of thecontainer of FIGS. 9A and 9B as being coated with an aluminum coating;

FIG. 11A is a partially enlarged perspective view illustrating theribbon liner of FIG. 9A being attached to the container via a one-wayretention tab;

FIG. 11B is a perspective view illustrating the ribbon liner of FIG. 9Abeing attached to the container via heat staked pins;

FIG. 11C is an enlarged partial perspective view illustrating the ribbonliner of FIG. 9A being attached to the container via a snap mechanism;

FIG. 12 is a perspective view illustrating a further embodiment for arectangular-shaped container of the present invention;

FIG. 13 is a schematic illustrating the pathways for air jets providedin a system of the invention and involves liquid cooling that isconverted into air flow cooling;

FIG. 14 is a top perspective view illustrating a carousel supporting adisposable cartridge, which in turn, is carrying a disposable optics cupand a plurality of air passageways in the carousel;

FIG. 15 is a bottom perspective view of the carousel of FIG. 14;

FIG. 16 is a schematic illustration of an arrangement of components fora spectrometer;

FIG. 17 is a graph illustration of the response of a grating used in thearrangement of FIG. 16 plotting the absorbance efficiency versus thewavelength of the illumination beam;

FIG. 18 is a perspective view illustrating an illumination arrangementof the optical reader of the invention;

FIG. 19 is an illustration showing the path of travel of the light beamfrom the light source to the specimen produced by the illuminationarrangement of FIG. 18;

FIG. 20 is a graph illustrating reflectance versus wavelength of theturning mirror within the illumination arrangement of FIG. 18; and

FIG. 21 is a schematic illustrating an optics cup positioned in theillumination arrangement of FIG. 18.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will be described with reference to theaccompanying drawings where like reference numbers correspond to likeelements.

For purposes of the description hereinafter, spatial or directionalterms shall relate to the invention as it is oriented in the drawingfigures. However, it is to be understood that the invention may assumevarious alternative variations, except where expressly specified to thecontrary. It is also to be understood that the specific componentsillustrated in the attached drawings, and described in the followingspecification, are simply exemplary embodiments of the invention. Hence,specific dimensions and other physical characteristics related to theembodiments disclosed herein are not to be considered as limiting.

FIGS. 1A-7 disclose “A System for Conducting the Identification ofBacteria in Urine” set forth in PCT Patent Application Publication No.US 2008/079533, filed on Oct. 10, 2008, which is commonly owned andherein incorporated by reference in its entirety. Referring to FIGS. 1A,1B, 2, 3A, 3B, 4A-4C, the system for conducting the identification ofbacteria in urine samples includes a disposable cartridge 12 (FIGS. 1Band 2); a sample processor 14 (FIGS. 3A, 3B, 6 and 7); and an opticalanalyzer 16 (FIGS. 4A, 4B, and 4C). As shown in FIGS. 1A and 2,cartridge 12 contains four disposable components, which are a centrifugetube 18, a first pipette tip 20 having a 1 ml volume, an optical cup orcuvette 22, and a second pipette tip 24 having a 0.5 ml volume. It is tobe understood that the presently described inventive system isappropriate for the identification of bacteria in any fluid and is notlimited to bacteria samples contained in urine.

The centrifuge tube 18 is a container that has an elongated body 18 bwith a tapered end indicated at 18 a. In general, the centrifuge tube 18initially contains the urine sample and the first pipette tip 20 may beused to dilute the urine-dissolved constitutes, and the second pipettetip 24 may be used to transfer the diluted urine sample into the opticalcup or cuvette 22 for optical analysis. The disposable cartridge 12 andits disposable components 18, 20, 22, and 24 may be made of a plasticmaterial which is easily molded and inexpensive to manufacture.

Still referring to FIG. 2, the disposable components 18, 20, 22, and 24are each contained within separate locations 30, 32, 34, and 36,respectively, of the disposable cartridge 12. As is shown, the bottom ofcompartment 32 which receives and carries the first pipette tip 20 isclosed so that any drip from the first pipette tip 20 will notcontaminate the surface below the disposable cartridge 12. Eachcomponent 18, 20, 22, and 24 is suspended within its respective location30, 32, 34, and 36 via a lip 40, 42, 46, and 48, respectively, attachedto each component 18, 20, 22, and 24, which is supported by the topsurface 50 of disposable cartridge 12.

Referring to FIGS. 2 and 4A, an optical cup or cuvette 22 may be used inthe optical analyzer 16 of FIG. 4A. Preferably, the urine samples areprepared with a saline solution since saline solutions minimizebackground fluorescence while maintaining the integrity of the bacteriawhich is particularly important when using optics in the urine analysisprocess. The optical cup or cuvette 22 will include a reflective coatingto assist in the optical analysis. The optical cup or cuvette 22 may bemade of an ABS plastic material, glass or a metallic material, e.g.,aluminum, and then coated with or layered with the reflective material.Alternatively, in the manufacturing of the optical cup or cuvette 22,the layer of reflective material may be incorporated onto the plastic,glass or metallic material. As best shown in FIG. 2, the optical cup orcuvette 22 includes a tapered end indicated at 22 a in order to assistwith the optical analysis. It is anticipated that the UV-light source inthe optical analyzer 16 (FIGS. 4A, 4B and 4C) be directed down themiddle of the cup or cuvette 22 for the optical analysis of the urinespecimen in the cup or cuvette 22.

Several disposable cartridges 12 each containing the four disposablecomponents 18, 20, 22, and 24 are then inserted into a magazine 26 shownat the top of FIG. 1A, which is then loaded into the sample processor 14as shown in FIG. 3A. Magazine 26 contains several disposable cartridges12 some of which are numbered, each cartridge 12 having a unique barcode as indicated at 28 in FIG. 1A that is paired with the specimen of apatient. Alternatively, the magazine 26 can then be inserted into adevice for the optical analysis of the urine samples. Preferably, thesame magazine 26 used in obtaining processed urine samples in a sampleprocessor is used in the device for the optical analysis of theprocessed urine samples.

The sample processor 14 of FIGS. 3A and 3B contains a centrifuge 31, acarousel 15 containing several disposable cartridges 12; a rotatabletable 41 supporting the carousel 15; an optical cuvette 22; a rotatablegripper mechanism 33 which picks up the centrifuge tube 18 (FIGS. 1A and1B) of each disposable cartridge 12 and inserts the centrifuge tube 18into the centrifuge 31; two movable fluid transfer arms 35, 35 a whichare used to dilute the dissolved material in the urine samples via thepipette tip 20 (FIGS. 1B and 2) and to transfer the diluted sample tothe optical cup or cuvette 22 (FIG. 2) via the pipette tip 24; and asyringe pump dispenser fluid system 37 for delivering water to thesamples for dilution purposes. The sample processor 14 also includes adrawer 38 which has a rotatable table 41 which receives, supports, androtates the magazine 26 when the drawer 38 is inserted into the sampleprocessor 14. The drawer 38 contains a magazine drive mechanism (notshown) which rotates the magazine 26. The sample processor additionallyincludes a centrifuge 31 for receiving centrifuge tubes 18 forcentrifuging the samples in the tubes 18; two movable fluid transferarms 35 and 35 a for diluting the dissolved material in the saline; anda syringe pump dispenser fluid system 37 for delivering clean fluid tothe samples for the dilution of the samples. Control unit 27 shown tothe right of FIG. 3A houses controls for ventilation, filtration andpower management for the sample processor 14.

The sample processor 14 also includes a drawer 38 for inserting carousel15 into the sample processor 14, a bar code reader 58 for identificationof cartridges 12, a pipetting system 43, and a metering system 45 formanaging the pipetting system 43 and dispenser fluid system 37.

In general, centrifuge tube 18 contains about a 2 ml sample of filteredurine which is placed into the centrifuge tube by the user. This samplemay then be sufficiently diluted with a saline solution or water bycentrifuging the sample followed by using the first pipette tip 20 withthe 1.0 ml volume to decant the supernates in two decant cycles followedby refilling of the centrifuge tube 18 with a saline or water. Thesecond pipette tip 24 having the 0.5 ml volume may then be used to drawout about 500 μl of fluid from centrifuge tube 18 and then to dispensethis 500 μl of fluid into the respective optical cup or cuvette 22 ofthe designated patient. This second pipette tip 24 can then be insertedinto the first pipette tip 20 and both pipette tips 20, 24 can bedisposed of properly. It is believed that one pipette tip may be used todilute and draw out instead of two pipette tips. This process may bedone manually or may be done automatically.

The loading and unloading of the magazine 26 is accomplished with theseveral disposable cartridges 12 mounted on the rotatable table 41 (FIG.1A). The manual drawer contains a magazine drive mechanism (not shown).Once the magazine 26 is inserted into the sample processor 14, the drivemechanism (not shown) for rotatable table 41 rotates the magazine 26;the bar code reader (element 58 in FIG. 4A) inventories the samples, alevel sensor (not shown) verifies that samples were dosed properly; anda second sensor (not shown) verifies that all of the necessarydisposable components 18, 20, 22, and 24 (FIG. 2) are contained in eachdisposable cartridge 12.

The transfer of the centrifuge tube 18 (FIG. 2) into the centrifuge 31(FIGS. 3A and 3B) will now be described. A centrifuge lid 31 a of thecentrifuge 31 is oriented to allow the rotatable gripper mechanism unit33 to access and load the centrifuge 31. The drive mechanism of therotatable table 41 is configured to align the centrifuge tube 18 of eachdisposable cartridge 12 into position relative to the rotatable grippermechanisms unit 33. The gripper 33 a of rotatable gripper mechanism 33selects the centrifuge tube 18 for transfer from the magazine 26 andinto the centrifuge 31. The centrifuge rotor (not shown) is configuredto align a vacant centrifuge holder of centrifuge 31 in the loadposition. The gripper 33 a, referred to as a “Theta Z gripper”, is aradial member that rotates and has a downward and upward movement forpicking up and setting a centrifuge tube 18 into a vacant centrifugeholder of centrifuge 31. The lid 31 a of centrifuge 31 is closed afterall of the centrifuge tubes 18 are placed into the centrifuge 31.

Centrifuge 31 (FIG. 6) is automatically operated to spin the centrifugetubes 18 at about a 12,000 g-force for about 2 minutes. The centrifuge31 includes tube holders that are configured to swing each of thecentrifuge tubes 18 about 90 degrees upon rotation of the centrifuge 31.The centrifuge allows for precise positioning and position tracking sothat correct tubes are returned to cartridges in the magazine aftercentrifugation. This action results in the solid formation of thebacteria present in the urine sample at the bottom of the centrifugetube 18.

There are two fluid transfer arms 35, 35 a (FIGS. 3A and 3B) forremoving the supernates from two samples of two disposable cartridges 12at a time. After the two fluid transfer aims 35, 35 a (FIGS. 3A and 3B)obtain the pipette tip 20 (FIG. 2) with a 1 ml volume, each of the fluidtransfer arms 35 and 35 a (FIGS. 3A and 3B) makes two consecutive tripsto the centrifuge tube 18, each time drawing fluid from the tube 18 anddispensing this fluid into a waste port (not shown) of sample processor14 before returning the pipette tip 20 to its location on the disposablecartridge that is being sampled and before continuing with the nextsample in the disposable cartridge 12 that is rotated to be registeredin the sampling location of sample processor 14.

The syringe pump dispenser fluid system 37 is illustrated in FIG. 7, fordelivering water or saline to the samples for dilution purposes. Thewaste fluid which had been decanted from a centrifuge tube 18 asdescribed in the preceding paragraph is replaced with clean processfluid via system 37. Two syringe pumps dispense this clean process fluidinto the centrifuge tube 18 from which the waste fluid had been removedin the previous step. During the final refill step, a smaller amount ofclean fluid is used in order to get the bacteria level in the centrifugetube 18 to the required concentration.

After the sample in centrifuge tube 18 has been sufficiently dilutedwith the clean fluid, one of the two fluid transfer arms 35, 35 a (FIGS.3A and 3B) transfers the processed sample in centrifuge tube 18 to theoptical cup or cuvette 22 of its respective disposable cartridge 12. Oneof the fluid transfer arms 35, 35 a grasps the pipette tip 24 having the0.5 ml volume, which until now has not been used in this process. Thispipette tip 24 with the smaller volume is used to draw out about 500 μlof fluid from centrifuge tube 18 and is used to dispense this fluid intothe respective optical cup or cuvette 22 of the designated patient. Thispipette tip 24 with the smaller volume is then inserted into the pipettetip 20 with the larger volume via the fluid transfer arm 35 or 35 a fordisposal of both pipette tips 20, 24.

The metering/decanting, metering/refilling, and metering/fluidtransferring process described herein is to obtain preferably,approximately a 1,000,000:1 dilution of the dissolved materialsretaining bacteria in the urine sample in centrifuge tube 18. This canbe achieved by 1) centrifuging through means known to those skilled inthe art, the urine sample at a 12,000 g-force; 2) decanting about 95% ofthe fluid by using the first pipette tip 20; 3) replacing the decantedsolution of 2) with a saline solution; and 4) repeating steps 1), 2),and 3) at least five times by using the first pipette tip 20. The finalprocessed urine sample in centrifuge tube 18 can then be decanted viathe second pipette tip 24 into the optical cup or cuvette 22.

The final processed urine sample in optical cup or cuvette 22 can thenbe used in an optical analysis for determining the micro-organism'sidentity and/or quantity in the urine sample in optical cup or cuvette22. This information can be obtained by using the system as disclosed inthe aforesaid U.S. Patent Application Publication No. 2007/0037135 A1.

Each of the steps described above for one centrifuge tube 18 is done inthe sample processor 14 for each of the disposable cartridges 12 inmagazine 26. It is to be appreciated that the waste fluid of eachdisposable cartridge 12 is disposed into a receptacle (not shown) insample processor 14 or is plumbed directly into a drain. The wastedisposables, i.e., the disposable cartridge 12 and disposable components18, 20, 22, and 24 remain on the magazine 26 for manual removal when themagazine 26 is unloaded in preparation for the next operation of thesample processor 14 for processing the next batch of urine samples.

The following steps are involved in processing the urine samples inpreparation for analysis via the optical analyzer 16 of FIGS. 4A, 4B,and 4C. In general, a sample of urine is obtained in a test tube. Thissample is passed through a 10 micron filter from which a 2 ml sample isobtained and placed into the centrifuge tube 18. The desired dilutedsample, i.e., 1,000,000:1 dilution of dissolved materials whileretaining bacteria in the urine sample is obtained by centrifuging this2 ml sample at about a 12,000 g-force; and decanting 95% of the fluid.This latter step is repeated five times wherein the decanted solution isreplaced each time with a saline solution. A saline solution is selectedfor this process in that it minimizes background fluorescence whichcomes into play when the processed urine sample is inserted into theoptical analyzer 16 while maintaining the bacteria integrity.

Referring to FIGS. 8A, 8B, and 8C, there is shown an alternativeembodiment for a disposable cartridge generally indicated as 112, whichmay be used for conducting the identification and quantification ofcontaminants, e.g., micro-organisms, e.g., bacteria in samples, e.g.,urine samples. Disposable cartridge 112 contains and carries severaldisposable components which include a centrifuge tube 118, a pipette tip120 and an optics cup or cuvette 122. With particular reference to FIG.8B, the pipette tip 120 has a predetermined volume, for example, rangingbetween 0.1 ml to about 10 ml, preferably 1 ml to 2 ml. The centrifugetube 118 is a container that has an elongated body 118 b with a taperedend indicated at 118 a. In general, the centrifuge tube 118 initiallycontains the sample and the pipette tip 120 may be used to dilute thedissolved sample constituents and then transfer the diluted urine sampleinto the optics cup or cuvette 122 for optical analysis. The disposablecartridge 112 and its disposable components 118, 120, and 122 may bemade of an ABS plastic material which is easily injection molded andinexpensive to manufacture.

Still referring to FIGS. 8A and 8B, the disposable components 118, 120,and 122 are each contained within separate compartments 130, 132, and134, respectively, of the disposable cartridge 112. As is shown, thebottom of compartment 132 which receives and carries the pipette tip 120is closed so that any drip from the pipette tip 120 will not contaminatethe surface below the disposable cartridge 112. Components 118 and 120are suspended within its respective compartment 130, 132 via a lip 140,142, respectively. Lips 140 and 142 are attached to its respectivecomponent 118 and 120, and are supported by a top surface 150 ofdisposable cartridge 112. In a similar manner, optics cup or cuvette 122is suspended within its respective compartment 134 via a flange 154 ofoptics cup or cuvette 122 which the flange 154 is supported by the topsurface 150 of disposable cartridge 112. The compartments 130 and 132are generally cylindrical shaped and extend substantially the length ofcentrifuge tube 118 and pipette tip 120. Compartment 134 for positioningsupporting optics cup or cuvette 122 is substantially enclosed withinthe disposable cartridge 112 and has a configuration similar to that ofoptics cup or cuvette 122.

The optics cup or cuvette 122 is a container and preferably includes areflective coating or layer to assist in the optical analysis. Theoptics cup or cuvette 122 is shown in FIGS. 9A and 9B and is discussedin further detail below. In particular, an inner surface of optics cupor cuvette 122 is coated with a reflective material or contains a layerof reflective material. The optics cup or cuvette 122 may be made of anon-reflective material, for example, an ABS plastic material or glassor it may be made of a metallic material, e.g., aluminum. In the latterinstance, that is, if the optics cup or cuvette 122 is made of anon-reflective material, it may be coated with or layered with thereflective material. Alternatively, in the manufacturing of the opticscup or cuvette 122, the layer of reflective material may be incorporatedonto the plastic or glass. As best shown in FIG. 9A, the optics cup orcuvette 122 includes the lower tapered area indicated at 124 in order toassist with the optical analysis of the specimen, and it is anticipatedthat the UV-light source provided in an optical analysis be directedinto the optics cup or cuvette 122 for the optical analysis of thespecimen, more about which is discussed herein below.

The disposable cartridge 112 preferably is injection molded and made ofan ABS plastic, preferably a non-reflective black colored plastic. Thedisposable cartridge 112 contains compartments 130, 132, and 134 forpositioning and supporting the centrifuge tube 118, pipette tip 120, andoptics cup or cuvette 122 discussed hereinabove. The compartments 130and 132 generally are cylindrical in shape so as to receive thecylindrical shapes of the centrifuge tube 118 and pipette tip 120 foradequate support of centrifuge tube 118 and pipette tip 120 within thedisposable cartridge 112. However, the compartment 134 for positioningand supporting the optics cup or cuvette 122, particularly if the opticscup or cuvette 122 is rectangular-shaped, need not be molded in the sameconfiguration as the optics cup or cuvette 122. In this instance, thecompartment 134 for supporting the optics cup or cuvette 122 indisposable cartridge 112 may, in general, include a rectangular-shapedopening 158 (FIG. 8A) located in the top surface 150 of the disposablecartridge 112 wherein the top flange 154 of optics cup or cuvette 122engages and is supported by the top surface 150 of disposable cartridge112 and the optics cup or cuvette 122 is suspended in the disposablecartridge. Alternatively, compartment 134 for positioning and supportingoptics cup or cuvette 122 may be totally enclosed and may have a similarconfiguration to that of rectangular-shaped optics cup or cuvette 122.

As discussed above and shown in FIG. 8C, several disposable cartridges112 each containing disposable components 118, 120, and 122 may beinserted into a magazine 126, which may then be inserted into a sampleprocessor 14 such as the processor shown in FIG. 3A. Each disposablecartridge 112 can have a unique bar code 128 which is paired with theinitial specimen of a patient. Alternatively, the magazine 126 may thenbe inserted into a device such as the optical analyzer 16 shown in FIG.4A for the optical analysis of the samples. Preferably, the samecarousel used in obtaining processed urine samples in a sample processoris used in the device for the optical analysis of the processed samples.

FIGS. 8D, 8E, and 8F show the disposable cartridge 112 without thedisposable components 118, 120 and 122 according to an embodiment of theinvention wherein attachment clips 113, 115, and 117 are provided. Theseattachment clips 113, 115, 117 extend in a horizontal direction along abottom edge portion of a side body portion 114 of the cartridge 112. Asshown in FIGS. 8D and 8E, attachment clip 115 may include a verticallyextending alignment member 116. This vertically extending member 116 canbe used for aligning the cartridge 112 during insertion into themagazine 126. The attachment clips 113, 115, 117 are configured tocooperate with the cartridge openings within the magazine 126, as shownin FIG. 8C, to form a snap fit arrangement therein to attach thecartridge 112 within this opening. Accordingly, in this embodiment, thecartridge openings within the magazine 126 can include appropriate clipopenings (not shown) which are configured to cooperate with the clips113, 115, 117 and alignment member 116 of the cartridge 112.

In general, centrifuge tube 118 may first contain, for example, between1 ml to about 2 ml sample of a filtered specimen. This sample may thenbe sufficiently diluted with a saline solution or water by centrifugingthe sample followed by using the pipette tip 120 to decant thesupernates in two decant cycles followed by refilling of the centrifugetube 118 with a saline or water. The pipette tip 120 may then be used todraw out a predetermined amount of fluid, e.g., 100 to 500 μl of fluidfrom centrifuge tube 118 and then to dispense this amount of fluid intoits respective optics cup or cuvette 122 of the designated patient.

The metering/decanting, metering/refilling and metering/fluidtransferring process described herein in the preceding paragraph may beused to obtain preferably, approximately a 1,000,000:1 dilution of thedissolved material in the sample while retaining contaminants, e.g.,bacteria in the sample, e.g., biological sample in centrifuge tube 118.This can be achieved by: 1) centrifuging, through means known to thoseskilled in the art, the sample at 12,000 g-force; 2) decanting about 95%of the fluid by using the pipette tip 120; 3) replacing the decantedsolution of step 2) with a saline solution; and 4) repeating steps 1),2), and 3) at least five times by using the pipette tip 120. The finalprocessed urine sample in centrifuge tube 118 can then be decanted viathe pipette tip 120 into the optics cup or cuvette 122.

The final processed sample in optics cup or cuvette 122 can then be usedin an optical analysis for determining the micro-organism's identityand/or quantity in the sample. This information can be obtained by usingthe system as disclosed in the aforesaid U.S. Patent ApplicationPublication No. 2007/0037135 A1.

FIGS. 9A and 9B illustrate an optics cup or cuvette, according to oneembodiment of the invention, generally indicated as 122, including arectangular-shaped container 123 having a well 156 and a rectangularopening 158 contiguous to well 156 for receiving a fluid sample which isthen carried in well 156. As stated above, the optics cup or cuvette 122may be made of glass or plastic, preferably, an injection moldedplastic. The fluid sample may be for example a biological, chemical ortoxicant sample, e.g., urine sample which is optically analyzed, forexample, for the type and amount of organism or micro-organism, e.g.,bacteria in the sample. Well 156 of container 123 is formed byspaced-apart sidewalls 160 and 162, spaced-apart first end wall 166 andsecond end wall 164, and a floor 168. Spaced-apart sidewalls 160 and 162and spaced-apart first and second end walls 166 and 164 form a flange170 contiguous to the rectangular opening 158. As shown in FIGS. 9A and9B, the first end wall 166 has an upper area 172 and a lower taperedarea 124 extending inwardly of upper area 172 of end wall 166 anddownwardly relative to upper area 172 of end wall 166 and therectangular opening 158 such that the length of floor 168 is less thanthe length of rectangular opening 158.

FIGS. 9D-9I illustrate an optics cup or cuvette, according to anotherembodiment of the invention, generally indicated as 722. The optics cupor cuvette 722 includes a rectangular-like shaped container 723 having awell 756 and a rectangular opening 758 continuous to well 756 forreceiving a fluid sample which is then carried in well 756. Similar tothe optics cup or cuvette 122, as described above in relation to FIGS.9A and 9B, the optics cup or cuvette 722 may be made of glass orplastic. The fluid sample to be received into well 756 may be, forexample, a biological, chemical or toxicant sample, e.g., urine samplewhich is optically analyzed, for example, for the type and amount oforganism or micro-organism, e.g., bacteria in the sample. Well 756 ofcontainer 723 is formed by spaced apart side walls 760 and 762,spaced-apart first end wall 766 and second end wall 764, and a floor768. Spaced-apart side walls 760 and 762 form a flange 770 contiguous tothe rectangular opening 758. A detailed view of the snap feature on theflange 770 is shown in FIG. 9I. As shown in FIGS. 9D, 9E and 9G, thefirst end wall 766 has an upper area 772 and a lower tapered area 724extending inwardly of upper area 772 of end wall 766 and downwardlyrelative to upper area 772 of first end wall 766 and the rectangularopening 758, such that the length of floor 768 is less than the lengthof rectangular opening 758.

The dimensions of the optics cup or cuvette 722 in the embodiment ofFIGS. 9D-9I are such that diversion and striations of the straight lightbeam have been optimized. In particular, as shown in FIG. 9F2, theopposed side walls 760 and 762 form a 3° angle B1, B2 in a directionextending outwardly as the side walls 760, 762 extend upwardly from thefloor 768 with respect to vertical line V1, V2 respectively. The anglesB1, B2 are measured from a location or fill-line 725 where the top of asample would be located within the optics cup or cuvette. The totaloffset angle between side walls 760 and 762 equals approximately 6°.Angling of side walls 760, 762 allows for better coating with areflective material, such as aluminum material as discussed below. Asshown in FIGS. 9E and 9G, the second end wall 764 has a top portion 764a and a bottom portion 764 b. The bottom portion 764 b can be angled atan angle B3 of between 1-3° in a direction extending outwardly as theside walls 760, 762 extend upwardly from the floor 768 with respect tovertical line V3 extending through the bottom of the optic cup orcuvette 122. At the location on fill-line 725, where the top portion ofa sample would be located in the optics cup or cuvette 122, the topportion 764 a of the second end wall 764 can have an additional 2° angleforming a total angle B3 of between 3°-5° with respect to the verticalline V3 in a direction extending outwardly as the side walls 760, 762extend upwardly from the floor 768. The angle A5 between the taperedarea 724 and the bottom portion 764 b of the second end wall 764 extendsat approximately 45.5°. The angle of the tapered area also extends atapproximately between 44.5°-45.5° with respect to the vertical plane V3extending through the optics cup. This angled tapered area 724 supportsaccurate beam travel back and forth as depicted by L3, shown in FIG. 21.

As shown in FIG. 9G, the lower taper area 724 is oriented with respectto the second end wall 764 such that an incoming illumination beam,illustrated by line L2, will hit and reflect, illustrated by line L3,from the lower taper area 724 to the lower portion 764(b) of the secondend wall 764, where it will be reflected back along line L4 to the lowertaper area 724, where it is reflected back along line L5. As a result,it is preferred that the deviation from a 45° angle of the angle A5 ofthe lower taper 724 is ½ the deviation of the angle B3 of the bottomportion 764(b) of the second end wall 764 from a vertical axis V3. Bydoing so, the illuminating beam will travel into the cup 722, reflectfrom the cup 722 along a parallel path and will not illuminate thebottom of the cup 722.

Reference is now made to FIG. 9G, which shows a schematic view ofmovement of light beams L2, L3, L4, and L5 in the optics cup or cuvette722. As stated above, at the location or fill-line 725, where the topportion of a sample would be located in the cup or cuvette 122, thelower portion 764 b of second wall 764 is angled at approximately 1°.Therefore, designing the angle of the tapered wall of the first wall 766such that it extends at a 44.5° angle with respect to the plane or lineV3, causes light beam L2 to contact tapered wall 764 b and redirect thatlight beam along path L3 where it reflects back from the bottom portion764(b) and once again, contacts the lower tapered area 724 and isdirected along line L5. The 44.5° angle of the lower tapered area 724,with respect to vertical plane V3, prevents skewing or misdirection ofthe light beam within the sample.

As illustrated in FIG. 9G, the bottom portion 764(b) may form an angleB3 of 1°, with respect to the vertical line V3, while the top portion764(a) may form an angle B4 of 3°, with respect to the vertical line V3.For better surface quality, when molding the cup 722, it may bedesirable to design the top portion 764(a) and bottom portion 764(b) asa single planar surface. Under these circumstances, the bottom portion764(b) would be oriented at an angle B3 of 3° and aligned with the topportion 764(a), thereby providing such a single planar surface. Such asingle planar surface, while not illustrated in the figures, may beeasily envisioned from examination of FIG. 9G. However, under thesecircumstances, to ensure the transmitted illumination beam L2 willreflect back upon line L5, the orientation of the lower taper area mustalso be changed to provide, for example, a surface with an angle A5 of43.5°.

Location of the snap features which are used to hold the cup within itslocation in the cartridge with respect to the longitudinal axis of theoptics cup or cuvette 722 is important to the beam location inside thevolume since the beam location on the angle surface as measured from thetop edge of that surface will determine the beam location from thebottom surface. The total area of the bottom floor 768 of the well 756can be approximately 84 mm². In a preferred embodiment, the snap featureis located on the side of the cuvette with the first end wall 766, asillustrated in FIG. 9I.

With particular reference to FIG. 9A, the optics cup or cuvette 122 alsoincludes a ribbon liner 174 which extends the full length of end wall164, floor 168, upper area 172 of end wall 166 and lower tapered area124 of end wall 166 to cover the inner surfaces of end wall 164, floor168, upper area 172 of end wall 166 and lower tapered area 124 of endwall 166. Ribbon liner 174 may be referred to as a “wet” ribbon linersince it comes into contact with the liquid sample from all sides.Ribbon liner 174 is preferably made of a reflective material, forexample, aluminum. Ribbon liner 174 may be made from a piece of stampedaluminum which may be pre-shaped to conform to the configuration formedby end wall 164, floor 168, lower tapered area 124 of end wall 166 andupper area 172 of end wall 166 prior to the installation of ribbon liner174 in well 156.

Optics cup or cuvette 122 may be made of a material known to minimizethe leaching of the contaminants from the material that might be excitedby the incident light used in an optical analysis of the sample. Asstated above, optics cup or cuvette 122 may be injection molded and madeof a material, for example, ABS plastic or glass. It is anticipated thatthe UV light provided in an optical analysis of the sample or specimenin container 123 of optics cup or cuvette 122 be directed into thetapered area 124 of well 156 for the optical analysis of the specimenand be reflected off of the ribbon liner 174, including the lowertapered area 124 of end wall 166. As discussed herein above, thematerial of optics cup or cuvette 122, the reflective material of ribbonliner 174 and the lower tapered area 124 of end wall 166 work in asynergistic manner to enhance the UV-light reflection to moreeffectively collect the fluorescence emission of the samples for theidentification and quantification of the organism or micro-organism,e.g., bacteria in the samples and at the same time minimize thebackground fluorescence and/or minimize the contamination of the samplefluid from the container or wetted surfaces of the container. Thecollection of the fluorescence emission of the sample from the optic cupor cuvette 122 is discussed in greater detail below.

FIG. 9B illustrates that alternatively, optics cup or cuvette 122 mayinclude a full liner 176, if light collection from the sidewalls 160 and162 as well as from the end wall 164, floor 168, the lower tapered area124 of end wall 166 and the upper area 172 of end wall 166 is needed forthe optical analysis of a sample. This full liner 176 is shaped andformed to substantially clad or cover the inner surfaces of sidewalls160 and 162, end wall 164, floor 168, lower tapered area 124 of end wall166 and the upper area 172 of end wall 166. The full liner 176 of FIG.9B functions similarly to the ribbon liner 174 in well 156 of optics cupor cuvette 122 of FIG. 9A with regard to the UV-light of the opticalanalyzer.

The ribbon liner 174 of FIG. 9A and full liner 176 of FIG. 9B may bepolished to obtain a desired degree of surface roughness for thereflection of the UV-light in optics cup or cuvette 122. The polishingprocess may either be performed on the reflective material used to formwet ribbon liner 174 or full wet liner 176 either when the reflectivematerial, i.e., aluminum is in raw sheet form prior to the stamping andforming process or when liners 174 and 176 are formed and inserted intooptics cup or cuvette 122 via a bulk polishing process. That is, thereflective material may either be polished before the stamping andforming process or the stamped parts may be polished.

FIG. 9C illustrates that the wet ribbon liner 174 of FIG. 9A may besecured to optics cup or cuvette 122 via a crimping process. In thisinstance, the one end 178 of wet ribbon liner 174 is bent to conformaround and under the outer contour of the portion of flange 154 formedby end wall 166 and end 178 is fastened to flange 154 via a crimpingprocess which is well known to those skilled in the art. Even though notshown in FIG. 9C, it is to be appreciated that the opposite end ofribbon liner 174 may be bent to conform around and then under the outercontour of the portion of flange 154 formed by end wall 164 and thenfastened to flange 154 via a crimping process.

It is to be further appreciated that even though not shown, in theinstance a full liner 176 of FIG. 9B is installed in optics cup orcuvette 122, that this liner 176 may be secured to flange 154 via acrimping process. The full liner 176 may be stamped and folded in aprogressive die and then singulated for installation in optics cup orcuvette 122. Both liners 174 and 176 may be wound on a reel and theoptics cup or cuvette 122 can be easily assembled in an automatedmanufacturing process. That is, the liners 174 and 176 may be on a reelso that a machine can be fed with the reels and the liners inserted intothe optic cups or cuvettes 122.

FIGS. 9A and 9B illustrate a reflective material for optics cup orcuvette 122 as being a separate piece that is manufactured, formed andshaped for insertion or installation into well 156 of container 123. Thepresent invention envisions that instead of liners 174 and 176, opticscup or cuvette 122 may be coated with a thin layer of reflectivematerial as indicated at reference number 180 in FIG. 10. In thisembodiment, optics cup or cuvette 122 may be injection molded with thedesired surface roughness and then coated with a thin layer ofreflective material 180, for example, pure aluminum, by either a vacuummetallization process or by an electroplating process. The industry hasshown that it may be difficult to coat inner surfaces of a containerthat has a certain depth. In this instance, customized electrodes mayneed to be provided to achieve the desired coverage and uniformity ofcoating in the well 156 of container 123 of optics cup or cuvette 122.The coating of reflective material 180 may extend totally along theinner surfaces of sidewalls 160 and 162, end walls 164 and 166 and floor168 of container 123 similar to the full liner 176 of FIG. 9B or thecoating may extend partially along the inner surfaces of end wall 164,the floor 168, lower tapered area 124 of end wall 166 and the upper area172 of end wall 164 of container 123 similar to the ribbon liner 174 ofFIG. 9A.

FIGS. 11A, 11B, and 11C illustrate additional systems for securingribbon liner 174 in container 123 of optics cup or cuvette 122.Specifically, FIG. 11A illustrates that the ribbon liner 174 may besecured to the portion of flange 170 formed by end wall 164 via aone-way retention tab 175 which is inserted through the ribbon liner 174and flange 170 in a manner known to those skilled in the art. Forexample, for this one-way retention tab, the container 123 has a postwhich has small “teeth” and the liner has a hole or opening and once theliner is positioned over the post, the “teeth” of the post prevent theliner from being moved and, therefore, slipping out of container 123.Even though not shown, it is to be appreciated that the opposite end ofribbon liner 174 may also be attached to the portion of flange 170formed by end wall 166 in a similar manner.

FIG. 11B specifically shows that the one end of ribbon liner 174 may besecured to the portion of flange 170 formed by end wall 164 and that theopposite end of ribbon liner 174 may be secured to the portion of flange170 formed by end wall 166 via heat staked pins 182 and 184. Heat stakedpins 182, 184 are also known to those skilled in the art. For example,in general, a heat stake pin 182, 184 is generally smooth and once theribbon liner 174 is positioned on the pin 182, 184, heat is used todeform the end so that the ribbon liner 174 is prevented from slippingout of the container 123.

FIG. 11C specifically shows that the one end of ribbon liner 174 may besecured in end wall 164 near flange 170 via a snap mechanism 186. Thissnap mechanism 186 may be formed in end wall 164 by stripping the moldedmaterial with a tool. If ribbon liner 174 is made of aluminum, ribbonliner 174 can be held securely in snap mechanism 186 since aluminum isflexible enough that it can be easily snapped into snap mechanism 186.Even though not shown in FIG. 11C, it is to be appreciated that end wall166 also includes a similar snap mechanism 186 for securing the oppositeend of ribbon liner 174 in container 123 of optics cup or cuvette 122.

FIG. 12 illustrates an optics cup or cuvette 188 having a two-piececonstruction including an upper piece 190 and a lower piece 192. Asshown, the upper piece 190 has a rectangular body 193 having arectangular opening 194 contiguous to flange 196, which in turn, isformed by spaced apart sidewalls 198 and 199 and end walls 200 and 201.Even though not shown, upper piece 190 is also fully opened at thebottom and has an indented portion 202. The lower piece 192 has arectangular opening 204 formed by spaced apart sidewalls 206 and 207 andend walls 208 and 209, and a floor 210. End wall 209 of lower piece 192has a tapered area 212 for re-directing the light. Tapered area 212extends down from the rectangular opening 194 and extends downwardly tofloor 210, thereby making the length of floor 210 less than the lengthof rectangular opening 204.

Both upper piece 190 and lower piece 192 are joined together viaindented portion 202 fitting into the rectangular opening 204 of lowerpiece 192 and these two pieces 190 and 192 may be bonded together via amethod selected from the group consisting of an ultrasonic, butt weldingprocess; an ultrasonic, shear welding process; a press fit process; asnap fit process; and a solvent welding process using either a press orsnap fit for fixing the two pieces 190 and 192 together during thebonding process. In this instance, the lower piece 192 is sufficientlyshallow as to enable the desired critical optical inner surfaces ofspaced apart sidewalls 206 and 207, end walls 208 and 209 and floor 210of lower piece 192 to be coated with a reflective material 180, such asaluminum, preferably via a vacuum metallization process in acost-effective manner compared to some of the disadvantages in using anoptics cup or cuvette 122 with a deep well 156 as discussed hereinabovewith reference to FIG. 10. The upper piece 190 may be regarded as askirt or a slosh shield thereby preventing the sample from flowing outof the optics cup or cuvette 188.

As may be appreciated, the upper flanges of optics cup or cuvette 122and 188 of the present invention may be used for supporting the opticscup or cuvette 122, 188 on a top surface 150 of a disposable cartridge112 used in magazines 126 for processing the samples and then opticallyanalyzing the samples. Also, the reflective surfaces of the optics cupor cuvette 122 and 188 are such that the UV light from the opticalanalyzer can be directed down into the cups or cuvettes and reflectedoff of the reflective surfaces and tapered areas as discussed in detailbelow to more efficiently and effectively produce the fluorescenceemission necessary in obtaining the required information for opticallyanalyzing the specimens for the identification and quantification of,for example, organisms or micro-organism, e.g., bacteria in thespecimens, e.g., urine specimens.

The optical analyzer 16 of FIGS. 4A, 4B, and 4C, as disclosed in PCTPatent Application Publication No. US 2008/079533 will now be described.While the drawings show cartridges 12 according to the embodimentillustrated in FIGS. 1A, 1B, and 2, it is recognized that thealternative cartridge of FIGS. 8A and 8F along with the cup or cuvettedesign 122 and/or 188 of FIGS. 9A-9C, 10, 11A-11C and 12 can also beutilized with the optical analyzer 16. With reference to FIG. 4A, theoptical analyzer 16 includes an optics system 44 (shown in greaterdetail in FIGS. 4B and 4C), a thermal control unit (not shown), a drawer51 which has a rotatable table 52 which receives, supports, and rotatesa magazine 54 containing a plurality of holders 56 for receiving thedisposable cartridges 12 in which optics cups or cuvettes 22 contain theprocessed urine samples which are to be analyzed, and a bar code reader58 (FIG. 4A).

As can be appreciated, a cartridge 12 or 112 that has the optics cups orcuvettes 22, 122 or 128 containing the processed urine sample foroptical analysis are placed into the holders 56 of the magazine 54. FIG.4A illustrates the magazine 54 mounted on the rotatable table 52 beingloaded into the optical analyzer 16. Drawer 51 is pulled out manuallyfor the loading and unloading of magazine 54. Drawer 51 contains thethermal control unit (not shown) and a drive mechanism (not shown).Alignment features on the magazine 54 and drawer 51 allow the operatorto orient the magazine 54 properly on the drive mechanism and thethermal control unit when the magazine 54 is loaded onto the rotatabletable 52. Once the drawer 51 and magazine 54 are manually inserted intothe optical analyzer 16, the drive mechanism rotates the magazine 54 atwhich time a bar code reader station 58 (FIG. 4A) inventories thesamples. A level sensor (not shown) verifies that each optical cup orcuvette 22 contains the correct sample volume. An operator can accessthe optical analyzer 16 when a user interface indicates that all thesamples in the optics cups or cuvettes 22 have been analyzed and drawer51 is prevented from being opened when any of the components of opticalanalyzer 16 are moving or when the UV-light sources of the optics system44 are on.

FIG. 4A illustrates the magazine 54 on rotatable table 52 while beingpositioned within optical analyzer 16. The optical analyzer 16 furtherincludes a mechanical locking system (not shown) which positions thedrawer 51 accurately with respect to the optics system 44. The drivemechanism is configured to automatically rotate the magazine 54 toposition each cartridge 12 into the bar code reader station 58 and intoprecise alignment with the optics system 44. A second mechanical lockingsystem (not shown) is used to secure each optics cup or cuvette 22 inits proper positioning relative to the optics system 44 for opticalanalysis.

FIG. 4A illustrates the thermal control for the optical cups or cuvettes22. Preferably, the temperature of each optics cup or cuvette 22 isdecreased to a temperature which will slow the metabolism of thebacteria while increasing the fluorescence signal. The thermal controlunit 47 which is a thermal electric cooler (TEC) cools a large thermalmass 60 which is located on the rotatable table 52 underneath themagazine 54. The thermal mass 60 (FIG. 4A) is in direct contact with theoptical cups or cuvettes 22.

In an alternative embodiment, the invention includes a system forcooling and controlling the temperature of a sample in the optics cup orcuvettes 22 carried by the disposable cartridges; cuvettes or optics cupof the invention. The system of the invention may find particularapplication in an optical analysis of the specimens in that thefluorescence signal will change with a change of temperature, thusresulting in an inadequate analysis of the specimens.

FIG. 13 illustrates a schematic for a system for delivering water, whichcools air, which, in turn, is delivered to cool specimens. Morespecifically, an optical analyzer 16 includes a housing 72 for enclosinga carousel 15 which supports a plurality of disposable cartridges (notshown), which, in turn, support an optics cup or cuvette (not shown)containing a specimen. A tubing system 74 surrounds the outer peripheryof a turntable 80 and includes an upper finned tubing 76 and a lowerfinned tubing 78, which carry water around the turntable 80. Asindicated by arrow A1 located to the left of FIG. 13, chilled water froma thermal electrical (TE) cooler (not shown) is delivered to upperfinned tubing 76, and as indicated by the arrow A2, located to the rightof FIG. 13, cool water is delivered from upper finned tubing 76 to theTE cooler or chiller at a rate of about 0.5 to 1.0 gallon per minute.The temperature of the chilled water delivered to the upper finnedtubing 76 is maintained between ±0.1° C. of a desired temperature forcooling the specimens. This is achieved by detecting the temperature ofthe cool water being delivered to the TE chiller, indicated by arrow A2,and using this information to adjust the water temperature of thechilled water being delivered from the TE chiller, indicated by arrowA1, to the temperature needed to adequately cool down and maintain thesamples at a desired temperature. The several thick, black arrows A3indicate that the air surrounding the lower finned tubing 78 is drawnupwardly into a Flatpak fan 82 (i.e., a low profile fan) and the severalthick, black arrows A4 indicate that the air from Flatpak fan 82 travelsinto the turntable 80 and upwardly into openings 84 of turntable 80 andthrough openings of carousel 15 as indicated by arrows A5.

As best shown in FIG. 14, an upper surface 86 of carousel 15 has aplurality of sections, some of which are indicated by reference number88. Each section 88 forms a cell and has an opening 90. The cool airdistributed by Flatpak fan 82 traveling from openings 84 of turntable 80travels through openings 90 and into its respective cell of sections 88.As best shown in FIG. 15, a lower surface 92 of carousel 15 has an innerhub 94, a number of radial ribs 96 extending from inner hub 94 and anouter ring 98 connected to radial ribs 96 and including the plurality ofopenings 90 for delivering the cool air into sections 88 mounted to theupper surface 86 of carousel 15. The openings 90 may be 0.156 inchholes. Since the carousel 15 has around 48 compartments or sections 88,and each compartment or section 88 has an opening 90, then the air flowrate of the jets of cool air being delivered through openings 90 andinto compartments or sections 88 may range from about 15 to 20 cubicfeet per minute.

Referring to FIGS. 14 and 15, it is to be appreciated that each section88 forming the carousel 15 supports a disposable cartridge 112, similarto the cartridge 112 as in FIGS. 2 and 3A. Each disposable cartridge 112contains a centrifuge tube 118, a pipette tip 120 and a disposableoptics cup or cuvette 122 (FIG. 14) for carrying a specimen. Thecentrifuge tube 118 and pipette tip 120 are generally used to prepareand process the sample in the disposable optics cup or cuvette 122 foran optical analysis of the contaminants, e.g., organisms in the specimenin the optical analyzer 16 of FIG. 13. Each cartridge is received withina compartment. As can be seen in FIG. 14, each compartment includes alower recessed lip portion that receives clips 113, 115, and 117. Also,the alignment member 116 is adapted to cooperate with one of theadjacent walls defining the respective compartments that receive thedisposable cartridge 112, so that alignment member contacts onecompartment wall and the other compartment wall contacts the wall 114opposite the alignment member 116 for horizontal alignment. Alignmentmember 116 is optional and is shown in phantom in FIG. 8E.

Preferably, the turntable 80 is made of aluminum and the disposablecartridges 112 and the optics cups or cuvettes 122 are injection moldedtransparent plastic.

Referring again to FIGS. 13 and 16, in the optical analyzer 16, thecarousel 15 made up of the sections 88 is supported by the turntable 80that locates and positions the optics cups or cuvettes 122 (FIG. 14) oneby one, under the optical system (not shown). The cooling system of theinvention as described with reference to FIG. 13 is intended to operateto cool the specimen in the optics cup or cuvettes 122 to the desiredtemperature. For example, each specimen may be cooled from an ambienttemperature down to a desired temperature, e.g. around 18° C. withinapproximately five minutes after start-up of the cooling system of FIG.13 and then the temperature may be controlled to within ±0.5° C. of thedesired temperature until the optical analysis of the samples iscompleted. Since the turntable 80 is aluminum, the disposable cartridges112 and optics cups or cuvettes 122 are plastic, and the optics cups orcuvettes 122 are supported in the disposable cartridges 12, which, inturn, are supported in the sections 88 of the carousel 15, convectivecooling is used to assist the cool jet airs traveling through openings90 and into sections 88 in the rapid cooling of the samples.

A further embodiment of the invention envisions a turntable similar tothat described and illustrated above with reference to FIGS. 13-15. Analuminum block is located below the turntable and has a plurality ofpassageways in association with the turntable for carrying chilled airfrom a TE chiller or cooler to the turntable and cool air from theturntable and, thus, the carousel to the TE chiller for cooling thesamples and then cooling the temperature of the specimens in a similarmanner described hereinabove with reference to FIGS. 13-15.

The optics system 44 of the optical analyzer 16 will now be described.The optics system is shown in greater detail in FIG. 4B. The opticssystem 44 contains three separate units, that is, an excitation unit44(a), an optical collection unit 44(b) and a spectrometer. Excitationwill be provided by an ultraviolet (UV) light source, which preferablywill be an LED (light emitting diode). A series of five LED modulesprovide an excitation unit 44(a) and will sequentially provideexcitation signals to each sample cup or cuvette 22, 122 or 188 at fivedifferent excitation wavelengths which will be applied to each samplecup or cuvette 22, 122 or 188 in the same order. The excitation timewill be approximately 14 seconds per wavelength. The excitationemissions are directed via lenses and filters 44(d) to be directed to anupper surface of the sample in the cuvette 22, 122 or 188. In order tonarrow or control the shape of each excitation wavelength, narrowbandwidth filters will be used. These filters will direct in adownwardly direction the excitation wavelengths E to the sample cups orcuvettes 22 and the fluorescent emissions F will be reflected back in anupwardly direction to the optical collection unit from the same positionof the cassette. The fluorescent emissions can be separated and directedvia a filter arrangement. FIG. 4C illustrates the positioning of theoptics system 44. As described previously, mechanical locking featuresposition the drive mechanism such that the sample cup or cuvette 22 isaligned precisely. This precise alignment allows for the reflection ofthe fluorescent emission to the optics system 44 allowing formeasurement of fluorescence. Optical elements (not shown) are utilizedto gather and direct the fluorescent emissions into the spectrometer formeasurement.

In addition, the optical collection unit includes optical elements togather and direct the fluorescent emissions of the samples in the cupsor cuvettes 122 into the spectrometer.

The optics system 44 (FIGS. 4B and 4C) may include a Czerny-Turnerspectrometer with a CCD (charged couple device) Photon Detector, wherebyfluorescent photons are reflected by several mirrors before contactingthe CCD device. The emitted fluorescence will be monitored on the CCDdevice by integrating for a period of time. It is also envisioned thatthe Czerny-Turner spectrometer be modified with additional cylindricallenses adjacent the entrance slit and the CCD device in order to improvephoton usage efficiency. Additionally, as schematically illustrated inFIG. 5, mirrored convex “horn” H may be provided at the entrance of theslit S of the spectrometer SM to direct additional photons through theslit S.

Referring to FIG. 4A, the optics system 44 will include a light-tightenclosure or housing 64 in order to minimize light entering the opticssystem 44, and the camera of the CCD device will include a thermalelectric cooler (TEC) (not shown) for transferring heat from the camerachip to the enclosure or housing 64 of the optics system 44.

The spectrometer of the optics system will now be described. Thearrangement of components for a spectrometer of the invention receivesan illumination beam which exits an optical collection system adjacentan optics cup or cuvette used in an optical analyzer which identifiesand quantifies the presence of contaminants, e.g., bacteria inspecimens.

Referring first to FIG. 16, a spectrometer 300 of the invention is usedin conjunction with an optical collection unit 232 having a plurality oflenses and an optics cup or cuvette 188 containing a urine specimen. Thespectrometer 300 includes a spectrometer slit 302 located immediatelyadjacent to the optical collection unit 232 and a first cylinder lens304 located immediately adjacent to the slit 302 in the same path oftravel for an illumination beam as that of the optical collection unit232 and optics cup or cuvette 188. A first collimating mirror 306 and asecond collimating mirror 308 are located to the far left of the firstcylinder lens 304, and a grating 310 is located to the bottom of opticalcollection unit 232. A second cylinder lens 312 and a CCD sensor 314 arelocated to the left of the grating 310 in FIG. 16.

The illumination beam enters optics cup or cuvette 188 from a lightsource (not shown) in a manner discussed above and fluorescent light isemitted out of optics cup or cuvette 188 and through the lenses of theoptical collection unit 232. From optical collection unit 232, thefluorescence beam travels through the spectrometer slit 302 and throughthe first cylinder lens 304. From first cylinder lens 304, thefluorescence beam travels along a first optical path and toward thefirst light collimating mirror 306. The beam is reflected fromcollimating mirror 306 and travels upon a second optical path throughgrating 310. The fluorescence beam in grating 310 is dispersed into aplurality of dispersed beams which are reflected off of grating 310 andtravel along a third optical path toward the second collimating mirror308. These dispersed beams strike the second collimating mirror 308which, in turn, focuses the dispersed beams toward and through thesecond cylinder lens 312 along a fourth optical path. From the secondcylinder lens 312, the dispersed beams are then received in the CCDsensor 314. The spectral information is captured by the CCD sensor 314for the optical analysis of the urine specimen in optics cup or cuvette188.

The first mirror 306, the second mirror 308 and the grating 310, arepreferably spherical in shape and have a 3-inch diameter. The grating310 preferably is a plane diffraction grating having 1200 lines permillimeter (lpm) and blazed 10.4° for a 300 nm wavelength region. Suchan appropriate grating is manufactured by and obtained from the NewportCorporation under product Model No. 53-030R.

A grating response for this type of grating 310 is illustrated in FIG.17, wherein line L1 represents the S-Plane, line L2 represents theP-Plane and line L3 represents the average of the S-Plane and theP-Plane. As can be appreciated from the graph of FIG. 21, the bestabsorbent efficiency occurs in the 300 to 400 nm wavelength region,which is the region of interest for the grating necessary in thespectrometer 300 of the invention.

Referring again to FIG. 16, the first cylindrical lens 304 and thesecond cylindrical lens 312 are made of fused silica and are componentsreferred to as components off the shelf or COTS. The first cylindricallens 304 located adjacent spectrometer slit 302 is located approximately10.7 mm from slit 302 and is a CVI Model No. CLCX-15.00-10.2-UV, and thesecond cylindrical lens 312 located adjacent to CCD sensor 314 is a CVIModel No. RCX-400 25.4-15.3-UV.

Still referring to FIG. 16, the first collimating mirror 306 adjacentthe spectrometer slit 302 has a nominal radius of about 400 m and thesecond collimating mirror 308 has a nominal radius of about 350 m. Theratio of the focal lengths of first collimating mirror 306 and secondcollimating mirror 308 is adjusted in order to fit the 300 to 420 nmspectrum of the illumination beam into the chip of the CCD sensor 314.

The CCD sensor 314 may be a Hamamatsu Model No. S7031-1008 chip which isapproximately 25 mm wide and 6 mm long. The CCD sensor 314 preferably isa single-stage cooled unit which uses thermal electrical cooling (TEC).For a bandwidth range of 300-400 nm, which is the wavelength range ofinterest for the present invention, the quantum efficiency of the chipfor the preferred CCD sensor 314 is approximately 50%.

Still referring to FIG. 16, the dimensions for the slit of thespectrometer slit 302 is nominally 2.8 mm wide and 5 mm long. Using asource bandwidth of 10 nm FWHM and a triangular function for the sourceoutput with wavelength, the spectral width of the system of FIG. 16 atthe plane of the CCD sensor 314 is 12.5 nm FWHM. The acceptance angle ofthe spectrometer 300 of FIG. 16 is approximately 0.4 NA(nano-Angstroms).

In the arrangement 300 of the invention, the first cylindrical lens 304tends to capture the additional radiation of the fluorescence beamexiting the spectrometer slit 302 and then direct the radiation throughthe optics system of FIG. 16. The second cylindrical lens 312 in closeproximity to the plane of the CCD sensor 314 tends to focus thisradiation onto the pixels in the CCD plane which are about 6 mm inlength. It is the inventor's position that the combination of the firstcylindrical lens 304 and the second cylindrical lens 312 enhances thethroughput of the spectrometer 300 of FIG. 20 compared to conventionalspectrometers which do not include lenses similar to lenses 304 and 312of the invention.

The spectrometer 300 of FIG. 16 may generally be similar to aCrossed-Czerny-Turner layout with the addition particularly of the firstcylindrical lens 304 and the second cylindrical lens 312 to create a lowresolution (less than 10 nm) but highly sensitive spectrometer for usewith wavelengths in the 300 nm to 420 nm range. The plane of the CCDsensor 314 represents a 25 mm length detector.

The sample processor 14 will have a HEPA air-filtering system forventilation purposes in filtering the air exiting the sample processor14.

It is further envisioned that the LED intensity will be monitored tocorrelate the emitted fluorescence with the intensity of the excitationfluorescence. In particular, the information obtained by the opticalanalyzer 16 may be used to generate graphs similar to FIGS. 5 through 9of U.S. Patent Application Publication No. 2007/0037135 A1, which iscommonly owned and herein incorporated by reference in its entirety,described in greater detail below. The graphs represent for theconcentration of the bacteria in the sample cups or cuvettes 22, thefluorescence intensity, the emission wavelengths and the excitationwavelengths.

An illumination arrangement for exciting and optically collecting lightin the optics cup or cuvette 122 used in an optical analyzer 16 whichidentifies and quantifies the contaminants in the sample is shown inFIGS. 18-21 and is discussed in more detail below.

A known measuring system is shown in U.S. Pat. No. 7,277,175 B2 whichdiscloses a system and method for wavelength selective measurement ofproperties of liquid samples. More specifically, the system includes alight source, an optical delivery system, at least two optical systems,a sample holding assembly, a filter assembly, and a transmission systemand a detector. The filter assembly may be a group of filters containedin a filter wheel. This system may provide for measuring properties ofsmall volume liquid samples that allows the insertion of selectivewavelength filters in an optical train in the vicinity of themeasurement location in order to increase the signal-to-noise ratio.However, this system does not provide for a compact optical readerhaving an increased signal-to-noise ratio for optically analyzing thebacteria in a urine specimen.

The present invention provides an improved optics system including anoptical reader that has a compact carriage train arrangement whichproduces and directs collimated light into a specimen for an opticalanalysis, while providing an increased signal-to-noise ratio for animproved analysis of the specimen. Referring first to FIG. 18, anoptical reader 214 of the invention includes an illumination arrangement216, a light source 218 for producing an illumination beam, a firstoptical system 220, a second optical system 221, an anchor shoe 222 anda filter wheel 223 located between the second optical system 221 and theanchor shoe 222. The light source 218 may be Xenon, LED's, deuterium andothers. Even though a filter wheel 223 is shown in FIG. 18, a linearvarying filter may be used. The first optical system 220 includes acarriage 224 having a housing 226 for supporting a turning mirror and afilter (not shown). The second optical system 221 includes a carriage228 having a housing 230 for supporting a turning mirror and a filter(not shown). As shown in FIG. 18, the carriage 224 of the first opticalsystem 220 extends into the housing 230 of the second optical system 221to connect the first optical system 220 to the second optical system221. The carriage 228 of the second optical system 221 extends into thefilter wheel 223 and into the housing 230 of the second optical system221 and into the anchor shoe 222 to connect the second optical system221 to the anchor shoe 222. The anchor shoe 222 includes a turningmirror (not shown) located to the right of a slot 222 a, as shown inFIG. 21, for receiving an optics cup or cuvette containing a fluidsample and an optical collection device 232 located above the slot 222 awhich contains a plurality of lenses (more about which is discussedherein below).

As is generally known to those skilled in the art, a filter is used totransmit light only in particular regions of the spectral and is used tochange or modify the total or relative energy distribution of a beam oflight. A turning mirror is at various location points to change thedirection that the light is traveling. A lens is used for focusing ornon-focusing light thereby allowing different optical effects. A slit isgenerally an opening having a specific shape. The light that passesthrough the slit travels to a grating and into a device, such as a CCDcamera for detection.

The illumination arrangement 216 of FIG. 18 further includes a filterwheel 223. As disclosed in column 4, lines 10-23 of the above-mentionedU.S. Pat. No. 7,277,175 B2, a filter wheel contains a group of filters,wherein a pre-selected filter may be placed in an optical path ofcollimated electromagnetic radiation. The pre-selected filtersubstantially selects transmission in a predetermined wavelength region.The filters generally are pre-selected based on the desired sample to bemeasured and the width of the spectrum of the absorption (or emission)band arising from the interaction of electromagnetic radiation and thesample. For a biological sample, electromagnetic radiation absorption iscentered at wavelengths (λ) ranging from 200 nm to 800 nm, mostly at 230nm, 260 nm and 280 nm.

The lenses used in the optical collection device 232 may be commercialoff-the-shelf (COTS) components.

FIG. 19 illustrates a typical illumination beam indicated at referencenumeral 234 showing a theoretical simulation of the beam path from alight source to a specimen produced by present day lens arrangements. InFIG. 23, a lamp or light source (not shown) is located to the left of afirst lens system H, I, J and K, and a second lens system isapproximately 8 inches away from the first lens system with the outputat an illumination shoe aperture (not shown) in the system which islocated to the far right in FIG. 19. In the invention, the length ofthis illumination beam 234 of FIG. 19 is reduced by the illuminationarrangement 216 of FIG. 18 wherein the illumination arrangement 216incorporates the filter wheel 223. Filter wheel 223 may carry aplurality of narrow band filters, i.e. in the ultraviolet range. In thisinstance, the radiation from light source 218 of FIG. 18 may berestricted to wavelengths ranging from 260 nm to 300 nm. Alternatively,filter wheel 223 may carry filters that provide the whole light spectrumand associated wavelengths. Also, as discussed herein above, a linearvarying filter may also be used instead of the filter wheel 223. Theturning mirrors (not shown) in the first optical system 220 and thesecond optical system 221 of the illumination arrangement 216 of FIG. 18are custom filters which predominantly reflect the ultraviolet band.

FIG. 18 illustrates a graph of custom filters which are Newport thinfilms provided by Newport Corporation, which are used as turning mirrorsin the first optical system 220 and the second optical system 221 of theillumination arrangement 216 of FIG. 18. As illustrated, these customfilters produce a relatively high reflectance that is about 100, in theultraviolet range that is in wavelengths ranging between 200 nm and 380nm and a low reflectance, i.e., 68 to lower than 10 in the visible light(VIS) and irradiation (IR) ranges, i.e., from about 400 nm to 608 nm.Thus, the filters may be VIS, NIR, and/or FIR rejecting filters.

The optical cup or cuvette 22 PCT Application US2008/079533, alsodiscussed in detail above and used in the cartridge 12 of FIGS. 1A, 1B,and 2 has an elongated cylindrical body and a lower tapered end. In thisdesign, the ultraviolet (UV) light source in the optical analyzer isdirected down the middle of the cuvette and into this lower tapered endfor the optical analysis of the biological specimen. The optical cup orcuvette 122 shown in FIGS. 12A-12C, 13, 14A-14C and cup or cuvette 188shown in FIG. 15, is designed to optimize the fluorescence sensing ofthe transmitted light rays in the cup or cuvette 122, 188.

FIG. 21 is a schematic of a side view of the anchor or injection shoe222 and optical collection device 232 of the illumination arrangement216 of FIG. 18, wherein an optics cup or cuvette 122, as discussedabove, is positioned within the slot 222 a of anchor shoe 222. It can beappreciated that optics cup or cuvette 722 may also be used with opticalcollection device 232.

Referring back to FIGS. 9A, 9I, 10, and 21, examples of the optics cupor cuvette 122, 722 are shown, which may be used in the optical readerof the invention. Optics cup or cuvette 122 includes arectangular-shaped container 123 having a lower tapered area 124 and aninner reflective surface. The container 123 further includes twoparallel spaced-apart sidewalls 160, 162, two spaced-apart end walls164, 166, and a horizontal floor 168, and wherein the first end wall 166includes the tapered area 124 which is contiguous to the horizontalfloor 168. According to one embodiment, as shown in FIGS. 9A and 9B, thewidth of the horizontal floor 168 of the optics cup or cuvette 122 isabout 7 mm, the depth of the sidewalls 160, 162 and the second end wall164 is about 18 mm, the depth of the first end wall 166 is about 11 mm,the length of the horizontal floor 168 is about 16 mm and the length ofthe tapered area 124 is about 7 mm. The tapered area 124 is angled atabout a 45° angle relative to the first end wall 164. According toanother embodiment, as shown in FIGS. 9D-9H, the width of the horizontalfloor 768 of the optics cup or cuvette 722 is about 5.6 mm, the depth ofthe side walls 760, 762 and the second end wall 764 is about 19.6 mm,the depth of the first end wall 766 is about 6.6 mm, the length of thefloor 768 is about 15 mm and the length of the tapered area 724 is, thetapered area extends at an angle of about 45.5° relative to a verticalplane.

Still referring to FIG. 21, the inner surface of optics cup or cuvette122 is reflective and preferably made of aluminum with a high qualitysurface finish or having a micro-roughness less than 50 angstroms. Theoptics cup or cuvette 122, 722 may be made of a low leaching andfluorescence signal material, for example, plastic or glass. Optics cupor cuvette 122 may be an injection molded plastic, which maysubsequently be subjected to a metallization step using evaporatedaluminum. This approach will allow a low cost mechanical fabricationwith a batch process coating. A further approach for manufacturingoptics cup or cuvette 122 for use in the invention is to use an aluminumfoil liner ribbon 174, as shown in FIG. 9A along the inner surfacelength of the container 123 which forms to the shape of the first endwall 164, the lower tapered area 124, the floor 168 and the second endwall 166 as discussed above. It can be appreciated that this aluminumfoil liner can be used with the optics cup or cuvette 722 of FIGS.9D-9I. According to the embodiment shown in FIGS. 9A and 9B, the volumeof the liquid specimen contained in the optics cup or cuvette 122 may beapproximately 955 μl.

Referring again to FIG. 21, a line L1 represents the incomingillumination beam. This illumination beam is produced by theillumination arrangement 216 of FIG. 22 and passes through a slit (notshown) which nearly collimates the illumination beam. The slit isapproximately a 4×4 mm square in cross-section and is located in theanchor shoe 222. The illumination beam is reflected into the optics cupor cuvette 122 using a turning mirror 235 located in the anchor shoe 222as discussed herein above. The first surface that a beam L2 encountersis the 45° inner surface of lower tapered area 124 of optics cup orcuvette 122. A reflected beam L3 traverses the optics cup or cuvette 122in the volume of liquid represented by a line L4. Upon striking thereflective inner surface of the second end wall 166, the beam returns tothe reflective inner surface of the 45° lower tapered area 124,fluorescence is emitted upwardly and out of optics cup or cuvette 122and toward the anchor shoe 222. The expansion of the beam is controlledby the optics system of the optical reader 214 (FIG. 18) of theinvention and generally may be about 5×5 mm in cross-section upon itsreturn to the anchor shoe 222.

It is to be appreciated that in view of the optics cup or cuvette 122,the beam in optics cup or cuvette 122 is directed such that it does notilluminate the bottom or floor 168 of the optics cup or cuvette 122during its traversal in the liquid volume of the specimen. Opticalcollection device 232 located above the slot 222 a contains a pluralityof lenses indicated at 236, 238, 240, and 242 and views the floor 168 ofthe optics cup or cuvette 122 and the liquid in the optics cup orcuvette 122 as indicated by lines L5, L6 and L7 which is representativeof the emitted fluorescent rays in FIG. 21. Approximately 47% of theliquid volume of the specimen is read by the optical fluorescentcollection device 232. By eliminating the illumination of the floor 168of optics cup or cuvette 122 and by restricting the optical collectiondevice 232 to view only the floor 168 and not the sidewalls 160, 162 andend walls 164, 166 of optics cup or cuvette 122 (FIGS. 9A and 9B), thebackground fluorescence of the optics cup or cuvette 122 as seen by theoptical collection device 232 can be minimized or nearly eliminated.Raytrace modeling indicates that a factor of 1000× less noise could betheoretically attainable. This is a huge advantage to achieving highersignal-to-noise ratios. By eliminating the noise of fluorescence fromthe optics cup or cuvette 122, the signal is more prominent, and higherfidelity and sensitivity can be achieved. Transmission of theillumination beam and measurement of the emitted fluorescence may occurin concert per sample or the illumination into the sample may stopduring the measurement of the fluorescence.

The following equation details the SNR (signal-to-noise ratio)calculation:

${S\; N\; R} = {\overset{S}{\sqrt{S + B_{f}}} + B_{r}}$

S represents the signal. B_(f) represents background fluorescence andB_(r) represents Raman background which occurs in view of the liquidwater in the specimen. For optical readers of the prior art, thesignal-to-noise ratio (SNR) is approximately 8.1 with over 1.5e6 noisephotons from fluorescence and 1e4 photons from the signal. In the designof the present invention, the noise is expected to be reduced to 1.5e4noise photons, while the signal is expected to increase to about 1.2e4photons. In view of these results, it is anticipated that the SNRproduced by the present invention will be about 73.

As discussed hereinabove, the optical analyzer 16 provides results thatare then used to identify the type of bacteria in the urine samples.This can be done by coupling the optical analyzer 16 to a computermodule (not shown) and feeding in the acquired information of theoptical analyzer 16, such as the fluorescence emission, into thecomputer module. The computer module may perform multivariate analysison the fluorescence excitation-emission matrices of the urine samples toidentify and quantify the urine samples in a manner similar to thatdisclosed in the above U.S. Patent Application Publication No. US2007/0037135 A1. Here, the system includes a fluorescence excitationmodule which includes an excitation light source, a sample interfacemodule for positioning the sample to receive the light source, afluorescence emission module and a detection device. The computer moduledescribed above is coupled to the fluorescence module. The multivariateanalysis may comprise extended partial least squared analysis foridentification and quantification of the urine samples.

It is still further envisioned that a “homogenitor tube” will be used tomix the different LED packages output into a uniform UV light source. Atypical “homogenitor tube” for use in the invention will be similar tothat known to those skilled in the art.

It will be understood by one of skill in the art that the fluid samplemay be for example a biological, chemical or toxicant sample, e.g.,urine sample which is optically analyzed, for example, for the type andamount of organism or micro-organism, e.g., bacteria in the sample.

The present invention has been described with reference to the preferredembodiments. Obvious modifications and alterations will occur to othersupon reading and understanding the preceding detailed description. It isintended that the invention be construed as including all suchmodifications and alterations.

The invention claimed is:
 1. An optics cup for holding a biologicalsample for use in an optical analysis comprising: a rectangular-shapedcontainer containing the biological sample, said container including apair of side walls, a first end wall, and a second end wall, saidcontainer having a rectangular opening for receiving the biologicalsample and a lower tapered area extending from the first end wall in aninwardly and downwardly direction relative to the rectangular opening,and, wherein the tapered area is angled at an angle A5 of betweenapproximately 43.5° and 44.5° relative to a vertical plane extendingthrough the optics cup, and wherein the lower tapered area cooperateswith the second end wall to reflect an incoming illumination beamthrough the sample and out of the container along a path that isparallel to the incoming illumination beam.
 2. The optics cup accordingto claim 1, wherein the angle A5 is approximately 43.5°.
 3. The opticscup according to claim 1, further comprising a wet ribbon liner forlight collection through the biological sample for the optical analysisof the biological sample.
 4. The optics cup according to claim 3,wherein the wet ribbon liner is made of a reflective material which isshaped and formed to partially clad the inside of the containerincluding the lower tapered area.
 5. The optics cup according to claim3, wherein the wet ribbon liner is made of a reflective material whichis shaped and formed to substantially clad the inside of the containerincluding the lower tapered area.
 6. The optics cup according to claim3, wherein the wet ribbon liner is fastened to a flange of therectangular opening of the container through a crimping process.
 7. Theoptics cup according to claim 3, wherein the ribbon liner is secured tothe flange of the rectangular opening of the container by at least aheat staked pin.
 8. The optics cup according to claim 3, wherein thecontainer further includes a snap mechanism and wherein the wet ribbonliner is secured to the container by the snap mechanism.
 9. The opticscup according to claim 1, wherein the cup is an injection molded cup andmade of a leaching resistance material for minimizing the amount ofcontaminants leached out of the biological sample.
 10. The optics cupaccording to claim 1, wherein the container is made from transparentmaterial.
 11. The optics cup according to claim 1, wherein the containerincludes an inner surface at least along the tapered area coated with alayer of reflective material.
 12. The optics cup according to claim 1,wherein each of the side walls of the container has an angle B1, B2 ofapproximately 3° in a direction outwardly as the side walls extendupwardly from the floor with respect to a vertical axis extendingthrough the rectangular opening.
 13. The optics cup according to claim1, wherein the illumination beam travels through the sample withoutilluminating a bottom surface of the container.
 14. The optics cupaccording to claim 1, wherein the incoming illumination beam is fedthrough the open portion of the container and into the sample which isthen reflected back in an upwardly direction out of the sample andthrough the open portion of the container.
 15. A disposable cartridgefor use in the identification and quantification of micro-organisms inbiological samples, comprising: a plurality of compartments forpositioning and supporting a plurality of disposable componentsincluding an optics cup containing the processed biological sample foruse in an optical analysis; the optics cup having a rectangular shapeand a tapered area extending from a first end wall of the optics cupinto which a light source travels for the optical analysis of theprocessed biological sample and a reflective surface for enhancing theoptical analysis, wherein the tapered area extends in a directionoutwardly as a second end wall extends upwardly from the floor at anangle A5 of between approximately 43.5°-44.5° with respect to a verticalplane extending through the optics cup, wherein the tapered areacooperates with the second end wall to reflect an incoming illuminationbeam through the sample and out of the container along a path that isparallel to the incoming illumination beam; and the compartment forpositioning and supporting the optics cup having a rectangular-shapedopening for receiving and supporting the rectangular-shaped optics cup.16. The disposable cartridge according to claim 15, wherein the angle A5is approximately 43.5°.
 17. The disposable cartridge according to claim15, wherein the disposable cartridge is injection molded and made of aplastic material.
 18. The disposable cartridge according to claim 15,wherein the compartment for positioning and supporting the optics cup issubstantially enclosed within the disposable cartridge and has aconfiguration similar to that of the optics cup.
 19. The disposablecartridge according to claim 15, including at least one attachment clipconfigured for cooperating with a magazine opening for attaching thecartridge therein.
 20. The disposable cartridge according to claim 15including at least one alignment member.
 21. The disposable cartridgeaccording to claim 15, wherein the illumination beam travels through thesample without illuminating a bottom surface of the container.
 22. Thedisposable cartridge according to claim 15, wherein the incomingillumination beam is fed through the open portion of the container andinto the sample which is then reflected back in an upwardly directionout of the sample and through the open portion of the container.
 23. Thedisposable cartridge according to claim 15, wherein the plurality ofdisposable components includes a centrifuge tube and a pipette tip. 24.The disposable cartridge according to claim 23, wherein the compartmentsfor positioning and supporting the centrifuge tube and the pipette arecylindrical shaped and extend substantially the length of the centrifugetube and the pipette.